[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Rules and Regulations]
[Page 54493-54496]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08se10-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2000-P-0924] (formerly Docket No. FDA-2000-P-1533)
Cardiovascular Devices; Reclassification of Certain Percutaneous
Transluminal Coronary Angioplasty (PTCA) Catheters
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is reclassifying the
device type, standard percutaneous transluminal coronary angioplasty
(PTCA) catheters, from class III (premarket approval) into class II
(special controls). Cutting/scoring PTCA catheters remain in class III
and continue to require premarket approval applications (PMAs). FDA is
reclassifying these devices in accordance with the Federal Food, Drug,
and Cosmetic Act (the act). Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a guidance document
entitled ``Guidance for Industry and FDA Staff: Class II Special
Controls Guidance Document for Certain Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheters'' that will serve as the special
control for the reclassified device type.
DATES: This final rule is effective October 8, 2010.
FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-6349.
SUPPLEMENTARY INFORMATION:
I. Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(the SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f)) of the act (21 U.S.C.
360c(f)) into class III without any FDA rulemaking process. Those
devices remain in class III and require premarket approval, unless and
until: (1) The device is reclassified into class I or II; (2) FDA
issues an order classifying the device into class I or II in accordance
with section 513(f)(2) of the act (21 U.S.C. 360c(f)(2)); or (3) FDA
issues an order finding the device to be substantially equivalent,
under section 513(i) of the act (21 U.S.C. 360c(i)), to a predicate
device that does not require premarket approval. The agency determines
whether new devices are substantially equivalent to previously offered
devices by means of premarket notification (510(k)) procedures in
section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the
regulations (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a PMA until FDA issues a final regulation under section
515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval.
Reclassification of postamendments devices is governed by section
513(f)(3) of the act (21 U.S.C.360c(f)(3)). This section states that
FDA may initiate the reclassification of a device classified into class
III under section 513(f)(1) of the act, or that a manufacturer or
importer of a device may petition the Secretary of Health and Human
Services (the Secretary) for the issuance of an order classifying the
device into class I or class II. FDA's regulations in 21 CFR 860.134
set forth the procedures for the filing and review of a petition for
reclassification of such class III devices. In order to change the
classification of the device, it is necessary that the proposed new
class have sufficient regulatory controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use.
Under section 513(f)(3)(B)(i) of the act, the Secretary may, for
good cause shown, refer a petition to a device panel. If a petition is
referred to a panel, the panel shall make a recommendation to the
Secretary respecting approval or denial of the petition. Any such
recommendation shall contain: (1) A summary of the reasons for the
recommendation, (2) a summary of the data upon which the recommendation
is based, and (3) an identification of the risks to health (if any)
presented by the device with respect to which the petition was filed.
II. Regulatory History of the Device
The PTCA catheter is a postamendments device classified into class
III under section 513(f)(1) of the act. Therefore, the device cannot be
placed in commercial distribution unless it is subject to an approved
premarket approval application (PMA) under section 515 of the act (21
U.S.C. 360e) or is reclassified.
On September 21, 2000, FDA filed a petition submitted under section
513(f)(3) of the act from COOK requesting reclassification of PTCA
catheters from class III into class II. This reclassification petition
did not include cutting or scoring PTCA catheters. In order to
reclassify the PTCA catheter into class II, it is necessary that the
proposed class have sufficient regulatory controls to provide
reasonable assurance of safety and
effectiveness of the device for its intended use.
The COOK petition requested reclassification of PTCA catheters from
class III to class II when indicated for balloon dilatation of a
hemodynamically significant coronary artery or bypass graft stenosis in
patients evidencing coronary ischemia for the purpose of improving
myocardial perfusion. Consistent with the act and the regulation, FDA
referred the petition to the Panel for its recommendation on the
requested changes in classification. FDA also asked the Circulatory
System Devices Panel for its recommendation on the reclassification of
PTCA catheters when used for treatment of acute myocardial infarction
(MI), treatment of in-stent restenosis (ISR) and/or post-deployment
stent expansion.
III. Device Description
FDA identifies this generic type of device, the subject of this
reclassification, as follows: Standard Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheter. A PTCA catheter is a device that
operates on the principle of hydraulic pressurization applied through
an inflatable balloon attached to the distal end. A PTCA balloon
catheter has a single or double lumen shaft. The catheter features a
balloon of appropriate compliance for the clinical application,
constructed from a polymer. The balloon is designed to uniformly expand
to a specified diameter and length at a specific pressure as labeled,
with well characterized rates of inflation and deflation and a defined
burst pressure. The device generally features a type of radiographic
marker to facilitate fluoroscopic visualization of the balloon during
use. A PTCA catheter is intended for balloon dilatation of a
hemodynamically significant coronary artery or bypass graft stenosis in
patients evidencing coronary ischemia for the purpose of improving
myocardial perfusion. A PTCA catheter may also be intended for the
treatment of acute myocardial infarction; treatment of in-stent
restenosis (ISR) and/or post-deployment stent expansion.
FDA is also issuing the following identification for the devices
that will remain in class III: A cutting/scoring PTCA catheter is a
balloon-tipped catheter with cutting/scoring elements attached, which
is used in those circumstances where a high pressure balloon resistant
lesion is encountered. A cutting/scoring PTCA catheter is intended for
the treatment of hemodynamically significant coronary artery stenosis
for the purpose of improving myocardial perfusion. A cutting/scoring
PTCA catheter may also be indicated for use in complex type C lesions
or for the treatment of in-stent restenosis.
IV. Recommendation of the Panel
At a public meeting on December 4, 2000, the Panel recommended
(seven to one) that PTCA catheters be reclassified from class III to
class II, when indicated for balloon dilatation of a hemodynamically
significant coronary artery or bypass graft stenosis in patients
evidencing coronary ischemia for the purpose of improving myocardial
perfusion; or for treatment of acute myocardial infarction. The Panel
did not recommend reclassification for PTCA catheters indicated for the
treatment of in-stent restenosis and/or post-deployment stent
expansion. The Panel recommended a guidance document, labeling, and
postmarket surveillance as special controls. The Panel stated that the
special controls will diminish some of the risks to health associated
with certain PTCA catheters. The guidance document and labeling
controls are intended to ensure the appropriate performance and use of
the device by physicians. The Panel recommended postmarket surveillance
as a special control to confirm that the other special controls being
applied to these devices would be sufficient to ensure that there would
not be an increase in adverse consequences to patients. In summary, the
Panel believed that class II with special controls would provide
reasonable assurance of the safety and effectiveness of the device.
The Panel recommended that PTCA catheters for the treatment of in-
stent restenosis and/or post-deployment stent expansion not be included
because of a lack of sufficient information about this use. Since the
Panel meeting, however, additional data regarding this use have become
available and have been reviewed by the agency.
FDA considered the Panel's recommendations and tentatively agreed
that PTCA catheters, other than cutting/scoring PTCA catheters, should
be reclassified from class III into class II because special controls,
in addition to general controls, would provide reasonable assurance of
the safety and effectiveness of the device, and there is sufficient
information to establish special controls to provide such assurance.
Although the Panel included the possibility of requiring postmarket
surveillance in their recommendation, FDA did not agree that specific
postmarket surveillance such as device tracking or postapproval studies
are needed for PTCA catheters. FDA believes that periodic assessment of
adverse event reports through medical device reporting submitted to the
agency is sufficient to address adverse effects caused by these devices
and is the least burdensome way to gather this data for PTCA catheters.
This practice is consistent with the manner in which these devices have
been regulated as class III devices since the Panel meeting.
Further, after a review of adverse event reports submitted to FDA's
Manufacturer and User Facility Device Experience (MAUDE) Database, the
agency believes that the types of risks associated with the use of PTCA
catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion are similar enough to the risks associated
with treatment of de novo lesions, such that the special controls
discussed at the Panel meeting, with the addition of recommendations
for specific nonclinical performance testing and the recommendation
that in-stent restenosis patients be included in the clinical
evaluation, when necessary, are adequate to control the risks to health
for these devices.
Accordingly, in the Federal Register of May 30, 2008 (73 FR 31123),
FDA issued the Panel's recommendation for public comment. FDA did not
receive any comments regarding the Panel's recommendation. Elsewhere in
this issue of the Federal Register, comments received regarding the
draft guidance document are addressed in the notice of availability
announcing the special controls guidance document.
V. FDA's Conclusion
After reviewing the data in the petition and presented at the Panel
meeting, and after considering the Panel's recommendation and the
comments on the notice of panel recommendation, FDA has determined that
the device type, standard percutaneous transluminal coronary
angioplasty (PTCA) catheters, can be reclassified from class III into
class II.
On August 19, 2010, FDA issued an order to the petitioner
reclassifying the devices into class II (special controls). The order
also identified the special control applicable to these devices as a
guidance document entitled ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters.'' This class II special controls guidance document is
now the special control for this device type.
An alternative approach to the special controls guidance document
may be used if such approach satisfies the applicable statute and
regulations.
Following the effective date of this final classification rule, any
firm submitting a 510(k) premarket notification for this device type
will need to address the issues covered in the special control
guidance. However, the firm need only show that its device meets the
recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
Accordingly, as required by 21 CFR 860.134(b)(6) and (b)(7) of the
regulations, FDA is announcing the reclassification of the standard
percutaneous transluminal coronary angioplasty (PTCA) catheters, from
class III into class II. In addition, FDA is issuing this final rule to
codify the reclassification of the device by adding new Sec. 870.5100.
VI. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Reclassification of this device type, from class III
to class II, will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements in section 515 of
the act (21 U.S.C. 360e). Because reclassification will reduce
regulatory costs with respect to this device, the agency certifies that
the rule will not have a significant economic impact on a substantial
number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
Based on an assessment of identified risks associated with the use
of PTCA catheters, FDA finds the requirements associated with a
premarket approval as a class III device do not provide an added public
health benefit over those that would result from the requirements under
a class II (with special controls). At the same time, PTCA catheter
manufactures, as makers of class III devices, bear all the costs
associated with a premarket approval, including the cost of submitting
the premarket approval application (PMA) and payment of user fees. One
previously published estimate (in 73 FR 7497) suggests that the costs
to prepare a PMA could potentially reach $1,000,000, in addition to
user fees of $217,787 in FY (fiscal year) 2010.
In contrast, if reclassification becomes final, manufacturers of a
PTCA catheter would pay a user fee of $4,007 for a 510(k) submission in
FY 2010. While we do not have data to estimate the cost of preparing a
510(k) submission, several different factors indicate that it would be
less than the cost of a PMA. For example, a firm does not have to
submit manufacturing information in its 510(k), which is required for a
PMA application, thereby reducing the burden and documentation needed.
Given the ability to evaluate nonclinical testing in a direct
comparison to a predicate device in a 510(k), FDA anticipates that most
new PTCA catheters will not require clinical data to support 510(k)
clearance, whereas all PMAs have to include some form of clinical data
to support PMA approval. This difference will result in a significant
reduction in cost for the device manufacturer. A PMA also requires the
sponsor to prepare a draft summary of safety and effectiveness
document, which is not required for a 510(k).
Based on the most recent 5 years, FDA estimates the following
annual number of submissions received for PTCA catheters: 15 ``30-day
Notice'' PMA supplements, 1 ``Normal 180-day Track'' PMA supplement,
and 2 ``Real-Time Process'' PMA supplements. (Note: FDA has not
received any ``Panel-Track'' supplements or original PMA submissions
for this device in the past 5 years.) A ``30-day Notice'' is submitted
for changes to a manufacturing process or method and assessed a user
fee of $3,485 in FY 2010. When reclassification is final, these types
of changes will not require clearance prior to the firm making the
change in the majority of cases. Modifications to the method of
manufacture of a device could require submission of a 510(k) if the
changes could significantly affect the safety or effectiveness of the
device, such as those that would currently require a ``Real-Time
Process'' or ``Panel-Track'' PMA supplement. Based on FDA's experience,
submission of a 510(k) for a modification to the method of
manufacturing would be rare.
In summary, this device reclassification would reduce the existing
burden on manufacturers of PTCA catheters. The application of class II
(with special controls) requirements would be consistent with the
principle of applying the least degree of regulatory control necessary
to provide reasonable assurance of safety and effectiveness.
VIII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. Section 4(a) of the Executive order
requires agencies to ``construe *** a Federal statute to preempt State
law only where the statute contains an express preemption provision or
there is some other clear evidence that the Congress intended
preemption of State law, or where the exercise of State authority
conflicts with the exercise of Federal authority under the Federal
statute.'' Federal law includes an express preemption provision that
preempts certain state requirements ``different from or in addition
to'' certain Federal requirements applicable to devices. (See section
512 of the act (21 U.S.C. 360k); Medtronic v. Lohr, 518 U.S. 470
(1996); Riegel v. Medtronic, 128 S. Ct. 999 (2008)). The special
controls established by this final rule create ``requirements'' for
specific medical devices under 21 U.S.C. 360k, even though product
sponsors have some flexibility in how they meet those requirements.
Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997).
IX. Paperwork Reduction Act of 1995
This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 is not required.
Elsewhere in this issue of the Federal Register, FDA is issuing a
notice announcing the guidance for the final rule. This guidance,
``Guidance for Industry and FDA Staff: Class II Special Controls
Guidance Document for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters,'' references previously approved
collections of information found in FDA regulations.
List of Subjects in 21 CFR Part 870
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 870.5100 is added to subpart F to read as follows:
Sec. 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheter.
(a) Standard PTCA Catheter--(1) Identification. A PTCA catheter is
a device that operates on the principle of hydraulic pressurization
applied through an inflatable balloon attached to the distal end. A
PTCA balloon catheter has a single or double lumen shaft. The catheter
features a balloon of appropriate compliance for the clinical
application, constructed from a polymer. The balloon is designed to
uniformly expand to a specified diameter and length at a specific
pressure as labeled, with well characterized rates of inflation and
deflation and a defined burst pressure. The device generally features a
type of radiographic marker to facilitate fluoroscopic visualization of
the balloon during use. A PTCA catheter is intended for balloon
dilatation of a hemodynamically significant coronary artery or bypass
graft stenosis in patients evidencing coronary ischemia for the purpose
of improving myocardial perfusion. A PTCA catheter may also be intended
for the treatment of acute myocardial infarction; treatment of in-stent
restenosis (ISR) and/or post-deployment stent expansion.
(2) Classification. Class II (special controls). The special
control for this device is ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters.'' See Sec. 870.1(e) for the availability of this
guidance document.
(b) Cutting/scoring PTCA Catheter--(1) Identification. A cutting/
scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring
elements attached, which is used in those circumstances where a high
pressure balloon resistant lesion is encountered. A cutting/scoring
PTCA catheter is intended for the treatment of hemodynamically
significant coronary artery stenosis for the purpose of improving
myocardial perfusion. A cutting/scoring PTCA catheter may also be
indicated for use in complex type C lesions or for the treatment of in-
stent restenosis.
(2) Classification. Class III (premarket approval). As of May 28,
1976, an approval under section 515 of the act is required before this
device may be commercially distributed. See Sec. 870.3.
Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-22304 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S